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PFIZER COMMENTS ON BEAUMONT HEART VALVE RESEARCH STUDY

 PFIZER COMMENTS ON BEAUMONT HEART VALVE RESEARCH STUDY
 NEW YORK, Oct. 23 /PRNewswire/ -- Pfizer, Inc (NYSE: PFE) today commented on the Beaumont Heart Valve research study. Physicians at William Beaumont Hospital in Royal Oak, Michigan, in an early and experimental use of x-ray technology, have identified a single-leg separation in a Bjork- Shiley Convexo-Concave heart valve implanted in a patient. The physicians operated successfully on the patient Wednesday, Oct. 21, removed the valve and replaced it with another mechanical heart valve.
 In the great majority of patients, the C-C valve has functioned to save, extend and improve the quality of patients' lives. In a small percentage of cases, the C-C valve has failed. Research suggests that sometimes one of the two legs of the valve's outlet strut may separate from the flange. This is called single-leg separation and is hypothesized to precede valve failure.
 "We are pleased that the identification of the separation by this experimental technique conducted by Beaumont Hospital may well have saved a life," said Philip Hedger, president of the Shiley Heart Valve Research Center (SHVRC), which commissioned the U.S. Food and Drug Administration-approved study. "We are encouraged that, in this instance, valve replacement surgery has confirmed that this x-ray technology correctly identified the single-leg separation."
 But Hedger emphasized that the identification of this one single-leg separation does not itself validate the x-ray technique as a diagnostic procedure. "It is still too early to determine if this technique will be useful for diagnosis," Hedger said. "However, we hope that the results of the study, once completed, will help confirm this."
 The FDA approved an investigative-study protocol on July 17, 1992 for a pilot study for people with C-C valves that have been judged to be at a higher risk. Under the direction of principal investigator William O'Neill, M.D. F.A.C.C., director of the Division of Cardiology, the Beaumont research team has evaluated almost 50 people to date. The research will continue until 300 people can be examined.
 "The Beaumont study of x-ray technology is a single element in Pfizer's and Shiley's commitment to the welfare of people with Shiley C- C valves." Hedger added. "But I must emphasize again that this approach has not yet been proven. Should the approach eventually be validated, its use will require further evaluation in light of other possible diagnostic techniques and screening procedures under study.
 "We remain concerned that, based on this early research finding, people may incorrectly assume this research program has already been successfully completed. This procedure is currently available only to C- C patients participating in the study and will not be generally available until approved by FDA," Hedger said. "We believe nonetheless that this first identification of a single-leg separation by Dr. O'Neill and his team at Beaumont Hospital--understood as one data point in the continuing experimental study--is a notable event that will be an element in the total evaluation of the study."
 Provisions to cover similar types of research, diagnostic and screening techniques and the costs of valve reoperations judged medically appropriate are embodied in the court-approved class action settlement, approved by a federal district court on Aug. 19, 1992 covering the approximately 50,000 people worldwide believed to be alive with C-C valves.
 -0- 10/23/92
 /CONTACT: Bob Fauteux, 714-250-8446, or Rick Honey, 212-573-2051, both of Pfizer/
 (PFE) CO: Pfizer Inc ST: New York, Michigan IN: MTC SU:


SH -- NY061 -- 4272 10/23/92 15:18 EDT
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Publication:PR Newswire
Date:Oct 23, 1992
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